Label: POLYETHYLENE GLYCOL 3350 powder, for solution
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NDC Code(s):
59556-762-00,
59556-762-01,
59556-762-02,
59556-762-03, view more59556-762-04, 59556-762-05
- Packager: Strides Pharma Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Polyethylene Glycol 3350, Powder for Solution
- Active ingedient (in each dose) (Can only)
- Purpose
- Active ingredient (in each dose) (Packet Only)
- Purpose
- Use
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Warnings
Ask a doctor before use if you have
- nausea, vomiting or abdominal pain
- a sudden change in bowel habits that lasts over 2 weeks
- irritable bowel syndrome
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Directions (Can Only)
- do not take more than directed unless advised by your doctor
- the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
- adults and children 17 years of age and older:
- use once a day
- fill to top of white section in cap which is marked to indicate the correct dose (17 g)
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- do not combine with starch-based thickeners used for difficulty swallowing
- ensure that the powder is fully dissolved before drinking
- do not drink if there are any clumps
- do not use more than 7 days
- children 16 years of age or under: ask a doctor
Directions (Packet Only)
- do not take more than directed unless advised by your doctor
- adults and children 17 years of age and older:
- use once a day
- stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- do not combine with starch-based thickeners used for difficulty swallowing
- ensure that the powder is fully dissolved before drinking
- do not drink if there are any clumps
- do not use more than 7 days
- children 16 years of age or under: ask a doctor
- Other Information
- Inactive ingredients
- Questions or comments?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Original
Prescription
Strength
Polyethylene Glycol 3350
Powder for Solution
Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
- Unflavored
- Sugar Free
- Dissolves in Any Beverage
ONCE-DAILY
DOSES
NET WT 4.15 OZ (119 g)
119 g CAN - FRONT
119 g BACK [CAN]
119g BACK [CAN]
119g BACK [CAN]
119g BACK [CAN]
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Original
Prescription
Strength
Polyethylene Glycol 3350
Powder for Solution
Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
- Unflavored
- Sugar Free
- Dissolves in Any Beverage
ONCE-DAILY
DOSES
NET WT 8.3 OZ (238 g)
238 G CAN - FRONT
238 G CAN - BACK
238 G CAN - BACK
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Original
Prescription
Strength
Polyethylene Glycol 3350
Powder for Solution
Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
- Unflavored
- Sugar Free
- Dissolves in Any Beverage
ONCE-DAILY
DOSES
NET WT 17.9 OZ (510 g)
510 g CAN - FRONT
510 g CAN - BACK
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INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59556-762 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Polyethylene Glycol 3350 (UNII: G2M7P15E5P) (Polyethylene Glycol 3350 - UNII:G2M7P15E5P) Polyethylene Glycol 3350 17 g in 17 g Product Characteristics Color WHITE (Colorless upon dissolution) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59556-762-04 238 g in 1 CAN; Type 0: Not a Combination Product 08/25/2016 2 NDC:59556-762-03 119 g in 1 CAN; Type 0: Not a Combination Product 08/25/2016 3 NDC:59556-762-05 510 g in 1 CAN; Type 0: Not a Combination Product 08/25/2016 4 NDC:59556-762-02 24 in 1 CARTON 08/25/2016 4 NDC:59556-762-00 17 g in 1 PACKET; Type 0: Not a Combination Product 5 NDC:59556-762-01 10 in 1 CARTON 08/25/2016 5 NDC:59556-762-00 17 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203928 08/25/2016 Labeler - Strides Pharma Inc (078868278) Establishment Name Address ID/FEI Business Operations Strides Pharma Science Limited 918513263 ANALYSIS(59556-762) , MANUFACTURE(59556-762) , PACK(59556-762)
